Surrozen, Inc./DE

Previous wording

We are developing SZN-8141 for the treatment of diabetic macular edema, or DME, and neovascular age-related macular degeneration, or wet AMD. SZN-8141 combines Frizzled 4, or Fzd4, agonism and vascular endothelial growth factor, or VEGF, antagonism and has the potential to provide benefits over treatment with single mechanism agents against these targets. The current standard of care for diabetic retinopathy (including DME), retinal vein occlusion and wet AMD is intravitreal administration of anti-VEGF therapies, including monotherapies and dual-pathway agents targeting VEGF and angiopoietin-2, or Ang-2. In addition, MK-3000, a Fzd4 monotherapy, has demonstrated proof of concept in DME in clinical trials. We believe SZN-8141 has the potential to treat multiple retinopathy indications and be differentiated from existing therapies. Data generated in preclinical models of retinopathy demonstrated that SZN-8141 stimulated Wnt signaling and induced normal retinal vessel regrowth while suppressing pathological vessel growth. We anticipate submitting an IND for SZN-8141 in the second half of 2026.

Current wording

We are developing SZN-8141 for the treatment of diabetic macular edema, or DME, and neovascular age-related macular degeneration, or wet AMD. SZN-8141 combines Frizzled 4, or Fzd4, agonism and vascular endothelial growth factor, or VEGF, antagonism and has the potential to provide benefits over treatment with single mechanism agents against these targets. The current standard of care for diabetic retinopathy (including DME), retinal vein occlusion and wet AMD is intravitreal administration of anti-VEGF therapies, including monotherapies and dual-pathway agents targeting VEGF and angiopoietin-2, or Ang-2. In addition, MK-3000, a Fzd4 monotherapy, has demonstrated proof of concept in DME in a clinical trial. We believe SZN-8141 has the potential to treat multiple retinopathy indications and be differentiated from existing therapies. Data generated in preclinical models of retinopathy demonstrated that SZN-8141 stimulated Wnt signaling and induced normal retinal vessel regrowth while suppressing pathological vessel growth. We anticipate submitting an IND for SZN-8141 by the end of the third quarter of 2026 and initiating a Phase 1b/2a study in patients with DME called DUET by year-end 2026.

Previous wording

We are developing SZN-8143 for the treatment of DME, wet AMD, and uveitic macular edema, or UME. SZN-8143 combines Fzd4 agonism, VEGF antagonism, and interleukin-6, or IL-6, antagonism and may have benefits over single mechanism agents against these targets. The current standard of care for diabetic retinopathy (including DME), retinal vein occlusion and wet AMD is intravitreal administration of anti-VEGF therapies, including monotherapies and dual-pathway agents targeting VEGF and Ang-2. In addition, MK-3000, a Fzd4 monotherapy, has demonstrated proof of concept in DME in clinical trials. We believe SZN-8143 has the potential to treat multiple retinopathy indications and be differentiated from existing therapies. Data generated in preclinical models of retinopathy demonstrated that SZN-8143 stimulated Wnt signaling and induced normal retinal vessel regrowth while suppressing pathological vessel growth.

Current wording

We are developing SZN-8143 for the treatment of DME, wet AMD, and uveitic macular edema, or UME. SZN-8143 combines Fzd4 agonism, VEGF antagonism, and interleukin-6, or IL-6, antagonism and may have benefits over single mechanism agents against these targets. The current standard of care for diabetic retinopathy (including DME), retinal vein occlusion and wet AMD is intravitreal administration of anti-VEGF therapies, including monotherapies and dual-pathway agents targeting VEGF and Ang-2. In addition, MK-3000, a Fzd4 monotherapy, has demonstrated proof of concept in DME in a clinical trial. We believe SZN-8143 has the potential to treat multiple retinopathy indications and be differentiated from existing therapies. Data generated in preclinical models of retinopathy demonstrated that SZN-8143 stimulated Wnt signaling and induced normal retinal vessel regrowth while suppressing pathological vessel growth.

Previous wording

In October 2022, we executed a Collaboration and License Agreement, or CLA, with Boehringer Ingelheim International GmbH, or Boehringer Ingelheim, to research, develop and commercialize Fzd4 bi-specific antibodies designed using our SWAP technology, including SZN-413. In September 2024, Boehringer Ingelheim decided to move forward with the development of SZN-413, which triggered a $10.0 million milestone payment to us. In March 2026, Boehringer Ingelheim achieved a research milestone, reflecting a positive outcome of the IND-enabling GLP toxicology study. We received the research milestone payment of $5.0 million from Boehringer Ingelheim in April 2026.

Current wording

In October 2022, we executed a Collaboration and License Agreement, or CLA, with Boehringer Ingelheim International GmbH, or Boehringer Ingelheim, to research, develop and commercialize Fzd4 bi-specific antibodies designed using our SWAP technology, including SZN-413. In September 2024, Boehringer Ingelheim decided to move forward with the development of SZN-413, which triggered a $10.0 million milestone payment to us. In March 2026, Boehringer Ingelheim achieved a research milestone, reflecting a positive outcome of the IND-enabling GLP toxicology study, which triggered a $5.0 million milestone payment to us. In June 2026, Boehringer Ingelheim achieved a development milestone following the initiation of a Phase 1 study, which triggered a $5.0 million milestone payment to us. We received each milestone payment of $5.0 million from Boehringer Ingelheim in April 2026 and July 2026, respectively.

Previous wording

Since our inception in 2015, we have devoted substantially all of our efforts and financial resources to organizing and staffing our company, business planning, raising capital, developing and optimizing our Wnt therapeutics platform, identifying potential product candidates, undertaking research and development activities, engaging in strategic transactions, establishing and enhancing our intellectual property portfolio, and providing general and administrative support for these operations. We have incurred operating losses since inception. During the three months ended March 31, 2026 and 2025, we incurred a net loss of $127.5 million and a net loss of $27.0 million, respectively. As of March 31, 2026, we had an accumulated deficit of $654.8 million and cash and cash equivalents of $106.9 million.

Current wording

Since our inception in 2015, we have devoted substantially all of our efforts and financial resources to organizing and staffing our company, business planning, raising capital, developing and optimizing our Wnt therapeutics platform, identifying potential product candidates, undertaking research and development activities, engaging in strategic transactions, establishing and enhancing our intellectual property portfolio, and providing general and administrative support for these operations. We have incurred operating losses since inception. During the three months ended June 30, 2026, we had net income of $50.2 million, including noncash gains of $59.6 million on changes in fair value of tranche liability and warrant liabilities during the period. During the six months ended June 30, 2026, we incurred a net loss of $77.3 million. During the three and six months ended June 30, 2025, we had net income of $39.7 million and $12.8 million, respectively, including noncash gains of $47.6 million and $104.6 million, respectively, on changes in fair value of tranche liability and warrant liabilities during the period. As of June 30, 2026, we had an accumulated deficit of $604.6 million and cash and cash equivalents of $102.0 million.

Previous wording

During the three months ended March 31, 2026, there were no material changes to our critical accounting policies or in the methodology used for estimates from those described under Part II, Item 7 “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2025.

Current wording

During the three and six months ended June 30, 2026, there were no material changes to our critical accounting policies or in the methodology used for estimates from those described under Part II, Item 7 “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2025.

Previous wording

The increase of $5.0 million in collaboration and license revenue for three months ended March 31, 2026, compared to three months ended March 31, 2025 is due to the recognition of a milestone achieved by Boehringer Ingelheim under the CLA in March 2026.

Current wording

The increase of $5.0 million in collaboration and license revenue for three months ended June 30, 2026, compared to three months ended June 30, 2025 is due to the recognition of a milestone achieved by Boehringer Ingelheim under the CLA in June 2026. See Note 5 to the unaudited condensed consolidated financial statements for information regarding the June 2026 development milestone and related contractual disagreement with Boehringer Ingelheim.

Previous wording

The increase of $2.8 million, or 42%, in research and development expenses for the three months ended March 31, 2026, compared to the three months ended March 31, 2025, is primarily due to a $2.4 million increase in manufacturing costs, lab expenses and consulting fees for SZN-8141 and a $1.2 million increase in employee-related expenses, offset by a $0.9 million decrease in clinical expenses as a result of the discontinuation of clinical development of SZN-043.

Current wording

The increase of $2.4 million, or 40%, in research and development expenses for the three months ended June 30, 2026, compared to the three months ended June 30, 2025, is primarily due to a $1.7 million increase in manufacturing costs, lab expenses and consulting fees for SZN-8141 and a $1.0 million increase in employee-related expenses primarily related to stock-based compensation, offset by a $0.3 million decrease in clinical expenses as a result of the discontinuation of clinical development of SZN-043.

Previous wording

The increase of $2.2 million, or 54%, in general and administrative expenses for the three months ended March 31, 2026, compared to the three months ended March 31, 2025 is primarily attributable to a $1.1 million increase in employee-related expenses and a $1.0 million increase in professional service fees.

Current wording

The increase of $2.9 million, or 74%, in general and administrative expenses for the three months ended June 30, 2026, compared to the three months ended June 30, 2025 is primarily attributable to a $1.5 million increase in employee-related expenses primarily related to stock-based compensation and a $1.3 million increase in professional service fees primarily related to the defense of our intellectual property portfolio.

Previous wording

The increase of $0.6 million in interest income for the three months ended March 31, 2026, compared to the three months ended March 31, 2025 is due to an increase in cash and cash equivalents.

Current wording

The increase of $0.5 million, or 40%, in interest income for the six months ended June 30, 2026, compared to six months ended June 30, 2025 is due to an increase in cash and cash equivalents.

Previous wording

The loss on amendment and cancellation of warrants for the three months ended March 31, 2025 was due to the non-cash change in the fair value of warrant liabilities resulting from the amendment of Series A and Series B common stock warrants and cancellation of Series C and Series D common stock warrants in connection with a private placement which was executed in March 2025, or the 2025 PIPE.

Current wording

The loss on amendment and cancellation of warrants for the six months ended June 30, 2025 was due to the noncash change in the fair value of warrant liabilities resulting from the amendment of Series A and Series B common stock warrants and cancellation of Series C and Series D common stock warrants in connection with the 2025 PIPE.

Previous wording

Loss on execution of the 2025 PIPE for the three months ended March 31, 2025 reflects the loss recognized upon the initial execution of the 2025 PIPE as the committed proceeds from the 2025 PIPE were less than the fair value of the tranche liability recognized at contract execution date. See Note 8 to the unaudited condensed consolidated financial statements for further information regarding the 2025 PIPE.

Current wording

Loss on execution of the 2025 PIPE for the six months ended June 30, 2025 reflects the loss recognized upon the initial execution of the 2025 PIPE as the committed proceeds from the 2025 PIPE were less than the fair value of the tranche liability recognized at contract execution date. See Note 8 to the unaudited condensed consolidated financial statements for further information regarding the 2025 PIPE.

Previous wording

The increase of $93.2 million in loss on change in fair value of tranche liability for the three months ended March 31, 2026, compared to three months ended March 31, 2025 was attributable to the non-cash change in fair value of tranche liability during the period, which was primarily driven by the increase in our stock price.

Current wording

The increase of $85.5 million in loss on change in fair value of tranche liability for the six months ended June 30, 2026, compared to six months ended June 30, 2025 was attributable to the noncash change in fair value of tranche liability related to the 2025 PIPE. The noncash loss was primarily driven by the increase in our stock price during the period.

Previous wording

The gain on settlement of tranche liability for the three months ended March 31, 2025 represents the proceeds from the sale of securities in the 2025 PIPE being greater than the net value of securities issued. The net value of securities issued constitutes the fair value of the securities issued, offset by the associated tranche liability remeasured at fair value on settlement date. See Note 8 to the unaudited condensed consolidated financial statements for further information regarding the 2025 PIPE.

Current wording

The gain on settlement of tranche liability for the six months ended June 30, 2025 represents the proceeds from the sale of securities in the 2025 PIPE being greater than the net value of securities issued. The net value of securities issued constitutes the fair value of the securities issued, offset by the associated tranche liability remeasured at fair value on settlement date. See Note 8 to the unaudited condensed consolidated financial statements for further information regarding the 2025 PIPE.

Previous wording

The increase of $79.1 million in other expense, net for the three months ended March 31, 2026, compared to the three months ended March 31, 2025, is primarily attributable to a $81.7 million non-cash change in fair value of warrant liabilities during the period, offset by $2.7 million financing transaction costs for the 2025 PIPE.

Current wording

The increase of $74.9 million in other expense, net for the six months ended June 30, 2026, compared to the six months ended June 30, 2025, is primarily attributable to a $77.5 million noncash change in fair value of warrant liabilities during the period, offset by $2.8 million financing transaction costs for the 2025 PIPE.

Previous wording

Since inception, we have only generated revenue from licensing and research collaborations. We incurred significant operating losses and negative cash flows from operations. Historically, we have financed our operations primarily through the sales of our equity securities and the payments received under our collaboration and license agreements. We anticipate that we will continue to incur net losses for the foreseeable future because of additional costs and expenses related to our research and development activities, including increased expenses from pipeline advancement and advancement of our product candidates into and through clinical developments and associated regulatory submissions, as well as increased general and administrative expenses related to audit, legal, regulatory, and tax-related services associated with maintaining compliance with the rules and regulations of the SEC and Nasdaq.

Current wording

Since inception, we have only generated revenue from licensing and research collaborations. We incurred significant operating losses and negative cash flows from operations. Historically, we have financed our operations primarily through the sales of our equity securities and the payments received under our collaboration and license agreements. We anticipate that we will continue to incur net operating losses for the foreseeable future because of additional costs and expenses related to our research and development activities, including increased expenses from pipeline advancement and advancement of our product candidates into and through clinical developments and associated regulatory submissions, as well as increased general and administrative expenses related to audit, legal, regulatory, and tax-related services associated with maintaining compliance with the rules and regulations of the SEC and Nasdaq.

Previous wording

In August 2025, we entered into a sales agreement with TD Securities (USA) LLC, or TD Cowen, to issue and sell up to $50.0 million of shares of common stock, or the 2025 ATM. The compensation payable to TD Cowen was up to 3.0% of the gross sales price of any shares sold pursuant to the sales agreement. During the three months ended March 31, 2026, we sold 1.4 million shares of common stock under the 2025 ATM for net proceeds of $26.9 million, after deducting sales agent commissions. In March 2026, we terminated the 2025 ATM and entered into a new sales agreement with TD Cowen to issue and sell up to $50.0 million of shares of common stock, or the 2026 ATM. The compensation payable to TD Cowen is up to 3.0% of the gross sales price of any shares sold pursuant to this new sales agreement. As of March 31, 2026, we had not sold any shares of common stock under the 2026 ATM.

Current wording

ATM for net proceeds of $26.9 million, after deducting sales agent commissions. In March 2026, we terminated the 2025 ATM and entered into a new sales agreement with TD Cowen to issue and sell up to $50.0 million of shares of common stock, or the 2026 ATM. The compensation payable to TD Cowen is up to 3.0% of the gross sales price of any shares sold pursuant to this new sales agreement. As of June 30, 2026, we had not sold any shares of common stock under the 2026 ATM.

Previous wording

The second tranche of the 2025 PIPE is contingent upon the public announcement of the receipt of clearance from the FDA on or prior to October 31, 2026 of our Investigation New Drug Application for SZN-8141, or the Second Closing Milestone. If we terminate our SZN-8141 program prior to October 31, 2026, then we will provide written notice to each purchaser, referred to as the Termination Notice, and each purchaser will have the right, but not the obligation, for 30 calendar days following the receipt of such notice, upon written notice to us, to purchase the additional shares of common stock, pre-funded warrants, and Series E common stock warrants subscribed for by such purchaser in the second closing. In addition, at any time prior to October 31, 2026 or the date of the Termination Notice (if earlier), in lieu of the requirement to purchase units in the second closing, each purchaser has the right, but not the obligation, upon five trading days’ prior written notice to us to purchase all (but not a portion) of the units subscribed for by such purchaser in the second closing, which we refer to as an Optional Closing. If a purchaser fails to purchase in full its subscribed for units after the achievement of the Second Closing Milestone in the second closing, or previously at the first closing or an Optional Closing, then the Series E common stock warrants issued to such purchaser shall automatically be cancelled and cease to be exercisable. In December 2025, in an optional closing we issued and sold 301,716 shares of common stock and Series E common stock warrants to purchase up to 150,858 shares of common stock for aggregate net proceeds of $3.3 million, after deducting placement agent fees and other expenses. Assuming achievement of the Second Closing Milestone, we will issue (i) 5,741,605 shares of common stock, (ii) pre-funded warrants to purchase up to 2,456,500 shares of common stock, and (iii) Series E common stock warrants to purchase up to 4,099,052 shares of common stock for aggregate gross proceeds of approximately $95.1 million in the second tranche. Please see Note 8 to the unaudited condensed consolidated financial statements for further information regarding the 2025 PIPE. During the three months ended March 31, 2026, Series E common stock warrants to purchase 34,000 shares of common stock were exercised for the gross proceeds of $0.4 million.

Current wording

The second tranche of the 2025 PIPE is contingent upon the public announcement of the receipt of clearance from the FDA on or prior to October 31, 2026 of our Investigation New Drug Application for SZN-8141, or the Second Closing Milestone. If we terminate our SZN-8141 program prior to October 31, 2026, then we will provide written notice to each purchaser, referred to as the Termination Notice, and each purchaser will have the right, but not the obligation, for 30 calendar days following the receipt of such notice, upon written notice to us, to purchase the additional shares of common stock, pre-funded warrants, and Series E common stock warrants subscribed for by such purchaser in the second closing. In addition, at any time prior to October 31, 2026 or the date of the Termination Notice (if earlier), in lieu of the requirement to purchase units in the second closing, each purchaser has the right, but not the obligation, upon five trading days’ prior written notice to us to purchase all (but not a portion) of the units subscribed for by such purchaser in the second closing, which we refer to as an Optional Closing. If a purchaser fails to purchase in full its subscribed for units after the achievement of the Second Closing Milestone in the second closing, or previously at the first closing or an Optional Closing, then the Series E common stock warrants issued to such purchaser shall automatically be cancelled and cease to be exercisable. In December 2025, in an optional closing we issued and sold 301,716 shares of common stock and Series E common stock warrants to purchase up to 150,858 shares of common stock for aggregate net proceeds of $3.3 million, after deducting placement agent fees and other expenses. Assuming achievement of the Second Closing Milestone, we will issue (i) 5,741,605 shares of common stock, (ii) pre-funded warrants to purchase up to 2,456,500 shares of common stock, and (iii) Series E common stock warrants to purchase up to 4,099,052 shares of common stock for aggregate gross proceeds of approximately $95.1 million in the second tranche. Please see Note 8 to the unaudited condensed consolidated financial statements for further information regarding the 2025 PIPE. During the three and six months ended June 30, 2026, 77,500 shares and 111,500 shares, respectively, of Series E common stock warrants were exercised for the gross proceeds of $0.9 million and $1.3 million, respectively.

Previous wording

As of March 31, 2026, we had cash and cash equivalents of $106.9 million and accumulated deficit of $654.8 million. We believe, based on our current operating plan, that our existing cash and cash equivalents will be sufficient to fund our operations for at least the next 12 months from the filing date of this Quarterly Report. In addition, if the FDA clears the IND application for SZN-8141 on or prior to October 31, 2026, the second closing of the 2025 PIPE will occur and we will receive an additional $95.1 million in gross proceeds which is expected to fund multiple ophthalmology programs through initial Phase 1 safety, tolerability and efficacy studies. We expect that in the long-term we will need to raise additional capital through public or private equity offerings, debt financings or other capital sources, including government grants, potential collaborations with other companies or other strategic transactions until we are able to generate revenue on our own. Our ability to continue as a going concern in the long-term is dependent upon our ability to successfully secure sources of financing and ultimately achieve profitable operations. There can be no assurance that sufficient funds will be available to us at all or on attractive terms when needed from these sources. If we are unable to obtain additional funding from these or other sources when needed, we may be necessary to significantly reduce expenses through reductions in staff and delaying, scaling back operations, or stopping certain research and development programs.

Current wording

As of June 30, 2026, we had cash and cash equivalents of $102.0 million and accumulated deficit of $604.6 million. We believe, based on our current operating plan, that our existing cash and cash equivalents will be sufficient to fund our operations for at least the next 12 months from the filing date of this Quarterly Report. In addition, if the FDA clears the IND application for SZN-8141 on or prior to October 31, 2026, the second closing of the 2025 PIPE will occur and we will receive an additional $95.1 million in gross proceeds which is expected to fund multiple ophthalmology programs through initial Phase 1 safety, tolerability and efficacy studies. We expect that in the long-term we will need to raise additional capital through public or private equity offerings, debt financings or other capital sources, including government grants, potential collaborations with other companies or other strategic transactions until we are able to generate revenue on our own. Our ability to continue as a going concern in the long-term is dependent upon our ability to successfully secure sources of financing and ultimately achieve profitable operations. There can be no assurance that sufficient funds will be available to us at all or on attractive terms when needed from these sources. If we are unable to obtain additional funding from these or other sources when needed, we may be necessary to significantly reduce expenses through reductions in staff and delaying, scaling back operations, or stopping certain research and development programs.

Previous wording

Cash used in operating activities of $12.5 million for the three months ended March 31, 2026 was primarily due to the use of funds in our operations, and the resulting net loss of $127.5 million and a net change of $5.6 million in our net operating assets and liabilities, offset by $120.6 million in non-cash charges. Cash used in operating activities of $9.3 million for the three months ended March 31, 2025 was primarily due to the use of funds in our operations, and the resulting a net loss of $27.0 million and a net change of $1.4 million in our net operating assets and liabilities, offset by $19.1 million in non-cash charges.

Current wording

Cash used in operating activities of $19.9 million for the six months ended June 30, 2026 was primarily due to the use of funds in our operations, and the resulting net loss of $77.3 million and a net change of $7.0 million in our net operating assets and liabilities, offset by $64.4 million in noncash charges. Cash used in operating activities of $15.4 million for the six months ended June 30, 2025 was primarily due to the use of funds in our operations, and the resulting net income of $12.8 million, offset by a net change of $0.8 million in our net operating assets and liabilities and $27.4 million in noncash charges.

Previous wording

Cash used in investing activities for the three months ended March 31, 2026 and 2025 was related to the purchases of lab equipment.

Current wording

Cash used in investing activities for the six months ended June 30, 2026 and 2025 was related to the purchases of lab equipment.

Previous wording

Cash provided by financing activities of $30.3 million for the three months ended March 31, 2026 consisted primarily of $26.9 million proceeds from the issuance and sale of common stock under the 2025 ATM and $3.3 million proceeds from issuance of common stock upon exercises of warrants. Cash provided by financing activities of $76.4 million for the three months ended March 31, 2025 consisted of the proceeds from the issuance and sale of common stock, pre-funded warrants and warrants in the 2025 PIPE.

Current wording

Cash provided by financing activities of $32.8 million for the six months ended June 30, 2026 consisted primarily of $26.9 million proceeds from the issuance and sale of common stock under the 2025 ATM, $5.5 million proceeds from issuance of common stock upon exercises of warrants and $0.4 million proceeds from issuance of common stock under our equity plans. Cash provided by financing activities of $71.3 million for the six months ended June 30, 2025 consisted primarily of the proceeds from the issuance and sale of common stock, pre-funded warrants and warrants in the 2025 PIPE.